Roundtable Topics

The biopharma sector has been growing incredibly fast over the past few years. Biologics are now the fastest growing class of therapeutics in the world, with the market growing at 7–8% in the United States and Europe and around 18% in India and China.
However, there are still some major challenges around affordability and access that need to be tackled before biologics become a realistic treatment option globally. Most of the manufacturing capacity is still located in the
traditional Western markets, and we need to develop fast, flexible and cost-efficient manufacturing solutions that spread biologics production more evenly, as a local presence has a central role in driving the increased availability
of these treatments.

Olivier Loeillot Senior VP, BioProcess, GE Healthcare

Transparency is the best policy. I learned from a consultant that, if you want to set yourself apart from your competition, you need to identify what people hate about your industry, and then find ways to correct that problem within your organization.
We know people hate negative surprises like delays and out-of-control costs, and just not knowing the status of their projects. That happens a lot with other CMOs.

Ed Price CEO, SEQENS North America CDMO (previously PCI Synthesis)

The pharmaceutical industry is continually evolving — from laboratory and research advances in life sciences to the rapidly expanding use of new technologies such as artificial intelligence, advanced analytics and robotics. The one thing that has remained
constant is our mission — to enable our customers to make the world healthier, cleaner and safer. This is the foundation for all that we do. We offer integrated solutions that help our customers bring medicines to the market.

Catalent formally introduced a corporate responsibility commitment in 2017 that cements our belief that ethical business practices are essential to fulfilling Catalent’s mission of helping people live better, healthier lives. Our corporate values, including
integrity and ethics, are at the foundation of our culture.

Shannon Trilli Director of Corporate Responsibility, Catalent

As a company, SGS takes ethics very seriously and conducts itself to the highest standard of professional behavior. The SGS Code of Integrity defines the main principles of professional integrity for the organization, and all staff — from the senior management
to entry-level employees — must complete the corporate integrity training program each year.

We are at a pivotal time in the pharmaceutical industry — advancing technologies, including the use of advanced analytics and artificial intelligence are transforming the development and manufacturing of new medicines. Analytics, using the enormous data
sets generated by drug development, are being used to develop systems that have the potential to predict the properties of new drug candidates.

AI is poised to play an increasingly important role, as the pharmaceutical industry understands itself more and more as a data- and knowledge-intensive enterprise — and as it engages in the full “healthcare package” of prevention, diagnosis, personalized
treatment and maintenance.

We believe that artificial intelligence (AI) and machine learning will play an increasingly important role in the diagnosis and prediction of disease — and will eventually become part of routine practice.

Ben Newton Chief Digital Officer, GE Healthcare Life Sciences

AI and robotics will help with analytics. The science we help clients with is getting increasingly complex, which means that the demand for increasingly sophisticated equipment, technology and training will continue to be important. We’re constantly evaluating
new equipment and approaches to see if they can handle the complexity, speed up processes and reduce overall costs.

Colorcon continues to provide solutions for pharmaceutical technology and manufacturing trends to meet the industry needs for coating flexibility and productivity while addressing patient adherence by making tablets easier to swallow.

The low cost and availability of IoT (internet-of-things) technology continues to have a significant impact on our company this year. Snapdragon develops chemical manufacturing processes that rely on the integration of a wide range of mechanical and electronic
components. We use IoT technology to coordinate the working of complex flow systems. We are also able to continuously harvest rich data sets from these systems with IoT-enabled sensors and process analytical technologies (PAT).
This combination of automated equipment and sensors in our laboratory systems enables automated experimentation. We can rapidly perform large numbers of experiments and gather incredibly rich data sets from every experiment.
This capability delivers much greater process knowledge and leads to more rapid process development and ultimately more efficient and controlled processes for drug substance and fine chemical manufacturing.

Matthew M. Bio, Ph.D.President and CEO, Snapdragon Chemistry, Inc.

Green chemistry is at the forefront of minds within the chemical industry, and utilizing our enzyme technology is becoming the norm rather than the exception. Within Arran Chemical Company (acquired by Almac in 2015), our AdaPT (Arran Deploys Advanced
Product Technologies) strategy and through a multi-million Euro investment and application of our selectAZyme™ technology, we have remained at the forefront of innovation to ensure our customers receive best-in-class solutions.
Our team has researched more than 30 projects in the last year involving multi-disciplinary research on enzyme optimization and chemical process design. Another key milestone was winning the Irish Industrial Chemistry Award
for the achievement of complete commercialization of an enzyme immobilization process involved in a medical device destined for the U.S. market.

Michael Cannarsa, Ph.D. Director of North American Business Development, Almac

As a busy CDMO, we are always looking for new opportunities to expand our toolbox, and this year was no different. There are several reasons for this. The first is to make development of cGMP materials faster, cheaper and more efficient for our sponsors.
To that end, we carefully evaluate new technology exhibited at the industry meetings we attend. For example, this year we have augmented our capabilities in cryogenics, micronization, large-scale chromatography and lyophilization,
to name just a few.

Ed Price President and CEO, PCI Synthesis

Although continuous flow has been utilized in similar industries for over a century, the pharmaceutical industry has been slow to adopt this technology for a variety of historical and regulatory reasons.

M&A has been a significant part of our growth strategy for a number of years. As an organization, we believe that growth is an integral part of being an industry leader. M&A provides us the opportunity to be more relevant to our customers — we don’t grow
for the sake of growth, or to move into areas we don’t understand; we grow to strategically improve our portfolio. We’ve acquired more than 35 companies over the past 15 years, including six in the past three years alone. Each
of those acquisitions has been the result of extensive due diligence, both into the companies we look at acquiring, and into our own to determine what areas make the most sense to grow.

For Catalent, acquisitions have been transformative for the growth and diversification of the company’s technologies and services offering, and in the last fifteen months alone Catalent has made three significant acquisitions in distinct parts of its
business, to address different strategic business needs.

Between 1993 and 2015, drug companies spent an estimated $1.7 trillion on M&A activity, with 74% of this activity attributed to only 20 companies. 2014 alone saw 185 deals, of which 22 were valued at more than $1 billion. This trend continues today with
nearly $34 billion being spent on M&A in the first quarter of 2017, and is likely to continue and perhaps even escalate. In particular, the political climate in the USA, advocating lower corporate tax rates and supporting repatriation
of overseas revenue, may provide pharmaceutical companies even more incentive to pursue acquisitions to augment their growth. This trend in M&A has been primarily driven by a need to compensate for reductions in growth as a
result of investment in early phase pipeline development, aptly demonstrated by the very recent, $11.9 billion acquisition of Kite Pharmaceuticals by Gilead.

Mark Rogers Global Technical Director, SGS Life Sciences

Almac Sciences, a business unit within the Almac Group, has grown organically since 2004 with a very respectable growth of more than 20% per year over 10 successive years. Recently, Almac Sciences has made some well-targeted acquisitions, with the first
being completed in November 2015 of Arran Chemical Company located in Athlone, Ireland. This focused on combining our strength, scale and technology. The impact on our business has been tremendous; the perfect combination of
large-scale intermediates manufacture (Arran asset) and biocatalysis (Almac technology platform) has successfully given us the right route-to-market for many of our clients’ development projects.

Michael Cannarsa, Ph.D. Director of North American Business Development, Almac

Recipharm has a clear merger and acquisition (M&A) strategy which is focused on expanding our capabilities as a full service CDMO, as well as our geographic presence.

Success in international markets is fundamental to the progression and growth of our pharmaceutical business. This demographic is driven by the geography of the market itself, in terms of current global pharmaceutical consumption and predicted regional
growth, as well as the regulatory requirement for regional testing to support global and local product registration.

Ever-increasing pressure on healthcare cost, a prevalent patent cliff, disharmonization of regulatory systems, increasing insolubility of new APIs, growing importance of generic and emerging market trends, etc. — the pharmaceutical industry is facing
a variety of major challenges. We at BASF acknowledge the responsibility, which the pharmaceutical industry holds in curing and keeping a growing and aging population healthy. Therefore, working together across value chain
steps and company borders gains more and more importance to develop reliable, sustainable and risk-mitigated solutions in a cost-effective and fast way. BASF has a long and successful history of actively partnering across company
borders. An example is BASF’s multi-level cooperation with Catalent. On the one hand, in the field of omega-3 fatty acid, Catalent offers custom encapsulation of the purest, high-quality molecules with best-in-class oxidation
stability. On the other hand, the development of new, more effective and patient-compliant dosage forms for pharmaceutical and nutritional use is part of joint developments. BASF helps to develop solutions that support Catalent’s
goals to bring high-performance, cutting-edge products cost-efficiently to the market. International and domestic partnership will remain more than ever a key to the success of this industry.

Kai Sievert Director Global Marketing, BASF Pharma Solutions

Working with an aim to foster strong partnerships with suppliers, service providers and other business parties makes it possible to standardize concepts and simplify the set-up and implementation of global projects.

International partnerships and collaborations are certainly critical for the success of Almac. Our customers are worldwide, with our business more or less evenly split between Europe, North America and Asia. Our suppliers are worldwide also. As an example,
we are managing a diverse biocatalysis business that uses enzymes developed at Almac to produce multi-tons of chiral building blocks, complex advanced intermediates and APIs. These projects require both a supply of raw materials
delivered to Ireland and REACH compliance. We have built an audited and reliable network of partners throughout continental Europe and in India for supply of raw materials and for manufacture of early synthesis steps. A recent
project involved a six-step process including an evolved lipase enzyme. To meet customer timelines and to utilize Almac reactor capacity most efficiently, the first step of the process was tech transferred to our Indian partner.
An Almac chemist went to India to ensure the process was tech transferred seamlessly and the Step 1 product was delivered to Ireland, where it was then forward processed. This business model of using an evolved enzyme developed
at Almac combined with manufacturing in India, Ireland and the UK provides our customers compelling economics for chiral building block and API supply.

Michael Cannarsa, Ph.D. Director of North American Business Development, Almac

In order to constantly serve its clients better and meet their ever-evolving needs, SGS Clinical Research has set up R&D partnership agreements with hospitals across Europe to enable access to relevant patient populations and therapeutic expertise. Under
these agreements, dedicated clinical pharmacology units are established within a hospital’s facility to conduct phase I inpatient clinical trials, which are undertaken by a permanent dedicated on-site SGS team. This team works
in close collaboration with hospital physicians, trial experts and investigators to ensure solid patient recruitment capacity and rapid subject enrollment, and maintain high-quality data collection and on-time study delivery.
These partnerships are beneficial in keeping the “partner hospitals” at the cutting edge of applied R&D, enabling their staff to gain greater expertise in early phase clinical trials, but most importantly, patients benefit
by having access to new therapeutic solutions as early as possible.